Premier
Inhalation SET, Trach,air-LON - Size 4
1manufacturer
111catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
Record
| Listed by | Premier Dental Products Co., United States |
|---|---|
| FDA product code | BTO |
| Device type | Tube, Tracheostomy (W/Wo Connector) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2015-09-18 |
| Record revised | 2026-06-24 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2026-06-23 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1034911 | In distribution | |
| 1034928 | In distribution | |
| 1034945 | In distribution | |
| 8100930 | In distribution | |
| 1034912 | In distribution | |
| 1034317 | In distribution | |
| 1037834 | In distribution | |
| 1050182 | In distribution | |
| 1034615 | In distribution | |
| 1034316 | In distribution | |
| 1034315 | In distribution | |
| 1034900 | In distribution | |
| 1034300 | In distribution | |
| 1034918 | In distribution | |
| 8100935 | In distribution | |
| 1034925 | In distribution | |
| 7350158 | In distribution | |
| 1050184 | In distribution | |
| 1034620 | In distribution | |
| 7350156 | In distribution | |
| 8100903 | In distribution | |
| 1034617 | In distribution | |
| 8100902 | In distribution | |
| 1037838 | In distribution | |
| 1034314 | In distribution | |
| 1034916 | In distribution | |
| 1050160 | In distribution | |
| 1037816 | In distribution | |
| 1037836 | In distribution | |
| 8100943 | In distribution | |
| 1050154 | In distribution | |
| 1034966 | In distribution | |
| 1034614 | In distribution | |
| 8100909 | In distribution | |
| 1034914 | In distribution | |
| 1034930 | In distribution | |
| 1034319 | In distribution | |
| 8100929 | In distribution | |
| 1034970 | In distribution | |
| 8100934 | In distribution | |
| 8100922 | In distribution | |
| 1034613 | In distribution | |
| 1034941 | In distribution | |
| 8100931 | In distribution | |
| 8100933 | In distribution | |
| 1034948 | In distribution | |
| 1037833 | In distribution | |
| 1034915 | In distribution | |
| 1050156 | In distribution | |
| 1034949 | In distribution | |
| 1034611 | In distribution | |
| 7350152 | In distribution | |
| 8100936 | In distribution | |
| 1034965 | In distribution | |
| 1034927 | In distribution | |
| 1034942 | In distribution | |
| 1034950 | In distribution | |
| 1034926 | In distribution | |
| 1034940 | In distribution | |
| 1050186 | In distribution | |
| 1050152 | In distribution | |
| 1037806 | In distribution | |
| 8100900 | In distribution | |
| 1034312 | In distribution | |
| 8100919 | In distribution | |
| 8100940 | In distribution | |
| 1034947 | In distribution | |
| 1034910 | In distribution | |
| 1050190 | In distribution | |
| 1034944 | In distribution | |
| 1050180 | In distribution | |
| 1034964 | In distribution | |
| 1034313 | In distribution | |
| 1050158 | In distribution | |
| 7350154 | In distribution | |
| 1037835 | In distribution | |
| 1034619 | In distribution | |
| 8100918 | In distribution | |
| 8100901 | In distribution | |
| 7350190 | In distribution | |
| 1034612 | In distribution | |
| 8100908 | In distribution | |
| 1034969 | In distribution | |
| 8100932 | In distribution | |
| 8100938 | In distribution | |
| 1050188 | In distribution | |
| 1034968 | In distribution | |
| 8100921 | In distribution | |
| 1034311 | In distribution | |
| 1034318 | In distribution | |
| 1034924 | In distribution | |
| 1034618 | In distribution | |
| 1034600 | In distribution | |
| 8100928 | In distribution | |
| 1037815 | In distribution | |
| 8100937 | In distribution | |
| 1034917 | In distribution | |
| 1034919 | In distribution | |
| 1034610 | In distribution | |
| 1034616 | In distribution | |
| 1034310 | In distribution | |
| 1034320 | In distribution | |
| 1037839 | In distribution | |
| 1034920 | In distribution | |
| 1034913 | In distribution | |
| 1034943 | In distribution | |
| 1050150 | In distribution | |
| 8100920 | In distribution | |
| 1037837 | In distribution | |
| 1034967 | Withdrawn | |
| 1034946 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tracoe® comfort | Tracoe Medical Gmbh | 1,296 |
| Portex | ICU Medical, Inc | 380 |
| Pilling | Teleflex Medical LLC | 248 |
| Tracoe mini | Tracoe Medical Gmbh | 110 |
| Sklar® | Sklar Corporation | 70 |
| Laryngotec | Andreas Fahl Medizintechnik-Vertrieb GmbH | 66 |
| Blom | Pulmodyne Inc. | 51 |
| Montgomery® Long-Term Cannula | Boston Medical Products, Inc. | 48 |
| Bivona | ICU Medical, Inc | 37 |
| Well Lead Tracheostomy Tube | Well Lead Medical Co., Ltd. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 36 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 30 |
Showing 12 of 77. All products under Tube, Tracheostomy (W/Wo Connector)
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.